ASCP/ASCP BOC Advocacy Repeals CMS Nursing Degree Policy:

CMS Final Rule abandons proposal to allow individuals with a bachelor’s degree in
nursing to perform high complexity tes>ng

On December 28, the Centers for Medicare & Medicaid Services (CMS) published in the Federal
Register a Final Rule on the Clinical Laboratory Improvement Amendments (CLIA) of 1988. This
regulaJon finalizes certain policies outlined in CMS’s July 26, 2022 Proposed Rule, which
included a proposal to recognize nursing degrees for purposes of non-waived tesJng. The
American Society for Clinical Pathology (ASCP) and the ASCP Board of CerJficaJon (ASCP BOC)
are pleased to report that the Final Rule provides quality paJent care with a massive advocacy
win. Not only did ASCP and the ASCP BOC succeed in prevenJng Bachelor of Nursing degrees
from qualifying individuals to perform high complexity tesJng, but we also succeeded in
reversing the CMS’s policy of considering nursing degrees to be equivalent to biology degrees.
The CLIA nursing degree policy has been an issue of significant concern for us for years. Given its
poten=al impact on pa=ent care, its repeal is one of our most important advocacy
accomplishments.
ASCP and ASCP BOC vigorously opposed the nursing degree proposal, leading other laboratory
organizaJons in opposiJon and securing more than 20,000 comments opposing the proposal
from ASCP members, BOC credential holders, and other members of the laboratory community.
(Almost 99 percent of the comments received by CMS used ASCP’s eAdvocacy plaXorm.)
In addiJon to laboratory personnel issues, the Final Rule addressed CLIA fees,
histocompaJbility, and alternaJve sancJons for CerJficate of Waiver laboratories. Due to the
many policy changes in the Final Rule, this report generally only addresses those policies
addressed in the ASCP and ASCP BOC’s August 25, 2022 comment le[er on the Proposed Rule.
Summary
In addiJon to the ASCP/ASCP BOC’s huge win on the nursing degree policy, CMS adopted several
other ASCP/ASCP BOC recommendaJons including: (1) establishing a degree equivalency
requirement, (2) eliminaJng physical science as a recognized degree for high complexity tesJng,
(3) clarifying training and experience requirements, (4) adopJng updated degree nomenclature
for medical laboratory science, and (5) updaJng the CLIA high complexity personnel
requirements for individuals compleJng a military laboratory training program. The Final Rule
does not adopt the ASCP/ASCP BOC recommendaJons to apply CLIA’s high complexity
personnel requirements to histology professionals, expand cerJficaJon requirements beyond
laboratory directors, or change the professional nomenclature for cytologists.

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The Nursing Degree
CMS agreed with the ASCP/ASCP BOC’s recommendaJon not to recognize a Bachelor of Nursing
degree as acceptable to perform high complexity tesJng. Importantly, CMS also acknowledged
in the rule the criJcal role that educaJon, training, and experience have on the work performed
by dedicated laboratory professionals. The following text from the Final Rule explains CMS’s
policy and raJonale.
“Aber consideraJon of the public comments, we are not finalizing the proposed
addiJon of a nursing degree (emphasis added) in the revised § 493.1489(b)(2)(i)
as a qualificaJon for high complexity laboratory tesJng personnel. High
complexity laboratory tesJng requires a higher level of knowledge; training and
experience; troubleshooJng and equipment maintenance skills; and
interpretaJon and judgement than moderate complexity tesJng. We believe that
individuals with biological or chemical science degrees, clinical laboratory science,
medical technology, and medical laboratory science have a be[er knowledge base
for high complexity tesJng (emphasis added). Nurses who have the appropriate
science courses and training may sJll qualify under § 493.1489(b)(2)(ii) and will be
evaluated on a case-by-case basis. When performing an analysis of all the
comments received, several addiJonal themes emerged, including the lack of
laboratory training that nursing professionals acquire, the addiJonal burden that
nurses would incur by performing high complexity tesJng, the concern for paJent
safety, and the differences between POC tesJng (which is classified as waived or
moderate complexity tesJng only) and high complexity tesJng. Beginning with the
effecJve date of this final rule, individuals with nursing degrees will only be able
to qualify for personnel posiJons listed in subpart M when a nursing degree is
specifically listed in the regulatory qualificaJons. Nursing degrees will qualify
under moderate complexity tesJng personnel. However, individuals with nursing
degrees will no longer be able to qualify as high complexity tesJng personnel. All
individuals, including those with nursing degrees, who are currently in posiJons
listed in subpart M prior to the effecJve date of the final rule will be
grandfathered as long as they meet the applicable grandfather provision,
including the requirement for conJnuous employment in their posiJon since the
effecJve date of the final rule.”
CMS’s degree equivalency (coursework) requirement and policy allowing nursing degree holders
to perform moderate complexity tesJng are consistent with previous ASCP/ASCP BOC
recommendaJons.
Physical Science and Degree Equivalency
Consistent with the ASCP and ASCP BOC’s recommendaJons, CMS finalized a proposal
eliminaJng physical science as a high complexity qualifying degree, as these degrees may not
provide sufficient knowledge and training to perform high complexity tesJng. CMS notes that
individuals with such degrees can sJll qualify to perform high complexity if they saJsfy the
agency’s new degree equivalency requirement.

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CMS’s degree equivalency requirement establishes a coursework algorithm allowing individuals
to qualify to perform high complexity tesJng even when they lack a degree tradiJonally used to
qualify to perform high complexity tesJng. CMS said in its Final Rule that the educaJonal
algorithm was based on comments received as part of its 2018 CLIA Request for InformaJon
(ROI). ASCP and the ASCP BOC proposed that CMS should establish a coursework requirement in
our comments on the 2018 ROI.
Individuals with physical science degrees who are currently performing high complexity tesJng
will be considered “grandfathered,” meaning the policy change will not affect their ability to
conJnue performing high complexity tesJng.
Training and Experience
ASCP and the ASCP BOC had urged CMS to clarify in the Final Rule that all personnel performing
non-waived tesJng must receive appropriate training and/or experience. In response, CMS
stated that it is clarifying that all tesJng personnel are “required to meet training and/or
experience requirements in addiJon to the educaJonal requirements to competently perform
their regulatory responsibiliJes.” Furthermore, CMS will also be requiring that “personnel
should have training or experience examining and performing tests on human specimens
(emphasis added) for the purpose of providing informaJon that is used in diagnosing, treaJng,
and monitoring an individual’s condiJon.” CMS will be requiring that prior tesJng experience in
research, veterinary, and forensic sekngs will no longer be considered applicable to the CLIA
personnel requirements. ASCP and the ASCP BOC supported this proposal.
Degree Terminology/Professional Nomenclature
Consistent with ASCP and ASCP BOC recommendaJons, CMS added medical laboratory science
to the CLIA regulaJon’s degree requirements. CMS noted in the rule, “Several commenters
noted the 2022 decision by AMT, ASCP, and ASCLS to change the MT cerJficaJon designaJon to
MLS…We agree with the commenters that medical laboratory science should be included in the
revised personnel qualificaJons.” The rule does not address updaJng the nomenclature for
cytologists. In comments on a 2023 CMS ROI, ASCP, ASCP BOC and others echoed the need
update CLIA’s nomenclature for these professionals.

Laboratory Directors
CMS has finalized its proposal affecJng laboratory director qualificaJons by adding a pathway
for moderate and high-complexity laboratory directors that do not have a tradiJonal earned
doctoral degree (PhD) in a chemical, biological, or clinical laboratory science, or medical
technology. CMS adopted its proposal to qualify individuals with a professional doctoral degree,
such as the Doctorate in Clinical Laboratory Science. These individuals must saJsfy CMS’s
doctoral-level educaJonal algorithm.
In addiJon, CMS will be requiring individuals qualifying with a tradiJonal doctoral degree AND
those qualifying under the new educaJonal pathway to have 20 CE credit hours (covering
applicable laboratory director responsibiliJes), cerJficaJon, and experience. These laboratory
directors will also be required to maintain their cerJficaJon. The ASCP and ASCP BOC supported
the use of CE to qualify physician laboratory directors who have significant experience in test

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performance but are no longer board eligible as well as the Agency’s proposal to require
maintenance of cerJficaJon for laboratory directors.
Cer=fica=on
In our comments on the 2022 Proposed Rule, ASCP and the ASCP BOC had recommended that
CMS require all supervisory-level personnel as well as personnel performing high complexity
tesJng to be cerJfied. While CMS has adopted its proposal that doctoral-level laboratory
directors must be cerJfied and to maintain this cerJficaJon, it did not extend this requirement
to other supervisory personnel or tesJng personnel.

Other Personnel Changes:

Military Laboratory Training Programs
CMS currently requires military laboratory personnel to meet the high complexity tesJng
personnel provisions intended for individuals with an associate degree. The provisions intended
for individuals who have completed a military medical laboratory procedures training course
required these individuals to qualify by April 24, 1995. A new provision has been established
requiring “Successful compleJon of an official U.S. military medical laboratory procedures
training course of at least 50 weeks duraJon and having held the military enlisted occupaJonal
specialty of Medical Laboratory Specialist (Laboratory Technician).” While not specifically
addressed in the ASCP and the ASCP BOC 2022 comment le[er, we have urged CMS to expand
high complexity qualifying opJons for individuals who have completed a military laboratory
training program.

Not Addressed in the Final Rule:

Histology Professionals
ASCP and the ASCP BOC urged CMS to treat histotechnology (pre-examinaJon and examinaJon
processes) as highly complex, thus requiring histotechnology professionals to meet CLIA’s high
complexity personnel requirements. CMS did not address this request in the Final Rule. This
should not be surprising, as the Agency raised the issue of applying personnel standards to
histology in a 2023 CMS ROI. The ASCP and the ASCP BOC recently echoed its long-standing
support for histology professionals in our comments on the 2023 CMS CLIA ROI.
Primary Source Verifica=on
While CMS states its willingness to accept Primary Source VerificaJon to verify individuals’
educaJonal credenJals, the rule did not address this issue in detail. ASCP and the ASCP BOC
have urged CMS to outline requirements for PSV as this could facilitate the hiring and
documenJng of laboratory professional competencies and laboratory inspecJons.
Pandemic/Public Health Preparedness
While ASCP and the ASCP BOC had urged CMS to task the Clinical Laboratory Improvement
Advisory Commi[ee with providing recommendaJons on pandemic/public health
preparedness, the rule was largely silent on the issue. ASCP and the ASCP BOC also asked CMS

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in its 2022 comments on the Proposed Rule to extend the allowance for pathologists and other
laboratory personnel to review digital images remotely. The Final Rule does not address this, as
we already scored an important win on this issue in 2023.
Effec=ve Dates
The rule has two effecJve dates. The Nursing Degree issue and other changes to Subpart M
(Personnel for Non-Waived TesJng) as well as the changes to Subpart K (Quality Systems for
Non-Waived TesJng) go into effect on December 28, 2024. The rest of the rule, e.g. fee
increases, goes into effect on January 24, 2024. This addiJonal Jme on the changes to the
personnel regulaJons is intended to provide laboratories with adequate Jme to adjust to these
new requirements.
Conclusion
Overall, ASCP and the ASCP BOC are very pleased with the Final Rule, as CMS adopted many of
our key CLIA advocacy prioriJes. We believe these policy changes will not only benefit paJent
care, but many of them will also help stabilize and strengthen the laboratory workforce. This is a
great accomplishment. ASCP and ASCP BOC greatly appreciate the important efforts of our
members, BOC credential holders, and others who have parJcipated in ASCP AcJon Alerts as
well as the many laboratory and pathology organizaJons we have partnered with on these and
other CLIA policy recommendaJons. Without this support and teamwork, these important
policy changes might not have happened. Thank you!!!

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